Dry EyeNCT04830956
Evaluation of Comfort in Subjects With Moderate Dry Eye Disease
A study testing FID123238 and Systane Hydration in people with Dry Eye, run by Alcon Research at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- FID123238 and Systane Hydration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Jun 2021to 10 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign an information consent letter
- Willing and able to follow instructions and maintain the appointment schedule
- Has dry eye symptoms
Who cannot join
- Has suffered any ocular injury to either eye in the past 12 weeks
- Is pregnant or lactating at the time of enrollment
- Other protocol-specified inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.
- Conditions
- Dry Eye
- Being tested
- FID123238, Systane Hydration
- Keywords
- Dry eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID123238Other
Lubricant applied to the ocular surface
Systane HydrationOther
Drops applied to the ocular surface
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. Receives: Other: FID123238; Other: Systane Hydration |
| Sequence 2 | Experimental | FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. Receives: Other: FID123238; Other: Systane Hydration |
| Sequence 3 | Experimental | FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. Receives: Other: FID123238; Other: Systane Hydration |
| Sequence 4 | Experimental | FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. Receives: Other: FID123238; Other: Systane Hydration |
| Sequence 5 | Experimental | FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. Receives: Other: FID123238; Other: Systane Hydration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in comfort rating
A visual analogue scale will be used
Measured: Baseline, up to 12 Hours (Day 1, each product)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start30 Jun 2021
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Dry Eye, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830956
- Sponsor's protocol ID
- DEJ475-E004
- Status last verified
- Nov 2021
- First submitted
- 1 Apr 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Comfort in Subjects With Moderate Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04830956
- Acronym / sponsor ID
- DEJ475-E004
- Conditions
- Dry Eye
- Keywords
- Dry eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Other: FID123238, Other: Systane HydrationFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. |
| Sequence 2 | Experimental | Other: FID123238, Other: Systane HydrationFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. |
| Sequence 3 | Experimental | Other: FID123238, Other: Systane HydrationFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. |
| Sequence 4 | Experimental | Other: FID123238, Other: Systane HydrationFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. |
| Sequence 5 | Experimental | Other: FID123238, Other: Systane HydrationFID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand and sign an information consent letter
- Willing and able to follow instructions and maintain the appointment schedule
- Has dry eye symptoms
Key exclusion criteria (3 listed)
- Has suffered any ocular injury to either eye in the past 12 weeks
- Is pregnant or lactating at the time of enrollment
- Other protocol-specified inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FID123238Lubricant applied to the ocular surface | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5 |
| Systane HydrationDrops applied to the ocular surface | Other | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5 |
Primary outcome
Change from baseline in comfort rating
Time frame: Baseline, up to 12 Hours (Day 1, each product)
A visual analogue scale will be used
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Dry Eye study director
Alcon Research, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FID123238 and Systane Hydration in people with Dry Eye, run by Alcon Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in comfort rating (time frame: Baseline, up to 12 Hours (Day 1, each product)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.